•Performs testing and associated tasks without errors per applicable SOPs and protocols.
•Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
•Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
• Performs bioburden and endotoxin testing on in process and final products
•Participates in cross-training to support staff availability within QC department
•Performs shift-work as necessary to support manufacturing operations.
• Responsible for aseptically sampling water, clean steam, environmental monitoring, and compressed gases per established sampling plans and protocols.
• Responsible for performing microbiological testing of water, clean steam, environmental monitoring, and compressed gases per established testing procedures and protocols.
• Responsible for performing Gram staining and microbiological identification of environmental monitoring samples
• Documentation of testing activities per cGMP requirements.
• Responsible for the review of laboratory data
• Authors Invalid and Out Of Specification (OOS) laboratory investigations
• Maintain inventory of all supplies and consumables for the laboratory.
• Flexible schedule and available to work weekends and overtime.
One year experience preferred in:
• Pharmaceutical Environmental Monitoring and Utility Monitoring programs
• Performing bioburden, Gram staining, microbial identification, and endotoxin testing for facility water as required
• Previous experience of sampling compressed gasses preferred
• Proficient in the use of Microsoft Word, Excel, and Laboratory information management systems preferred.
-Ranked Top 500 Asian-Owned & Asian Pacific American-Owned Businesses in the US -Ranked Top 100 Diversity-Owned & Privately-Owned Businesses in California -Ranked INC500 Fastest Growing Private Companies -Ranked Top 100 Largest Women Owned Business San Francisco Business Times -Ranked 50 Largest Minority-Owned Companies San Francisco Business Times - Ranked in Top 100 Woman Owned Business in the US, Diversity Business -Ranked in the Top 10 Minority-Owned Businesses in the Philadelphia Business Journal -Ranked in the Top 50 Woman-Owned Businesses in the 2014 Philadelphia Business Journal